Together Overcoming Diabetes - Great Plains

January 22, 2026 updated by: Johns Hopkins Bloomberg School of Public Health

Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota

The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Courtney Claussen, PhD
  • Phone Number: 605-200-0043
  • Email: cclauss1@jh.edu

Study Locations

  • United States
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Center for Indigenous Health - Great Plains Hub
        • Contact:
          • Courtney Claussen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria - Adult Index Participants:

  • 18 years and older
  • Self-identifies as American Indian or Alaska Native
  • Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
  • Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
  • Caregiver to a 10- to 25-year-old in their home at the time of screening.
  • Willing to complete all implementation and follow-up assessments.
  • Willing to be randomized for the intervention.

Exclusion Criteria - Adult Index Participants:

  • Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
  • Willing to serve as 'support person' for the adult participant.
  • Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

Inclusion Criteria - Youth Support Participants:

  • Between 10 years and 25 years old
  • Self-identifies as American Indian or Alaska Native.
  • Willing to serve as 'support person' for the adult participant.
  • Willing to complete all implementation and follow-up assessments.
  • Willing to be randomized for the intervention.

Exclusion Criteria - Youth Support Participants:

  • Cognitively or visually impaired
  • Youth in foster care (due to potential mobility of foster youth).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Behavioral: Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Experimental: Together Overcoming Diabetes Intervention
Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families
Behavioral: TOD Great Plains
The adapted TOD intervention is rooted in the original TOD structure, delivery system, and home-visiting teaching schedule. Local enhancements include intervention topics and activities to address local adult caregivers' diabetes management and to promote families' modifiable risk and protective factors targeted by this proposal and informed by the Wicozani wellness concept and measurement. The TOD intervention includes targeted content taught approximately bi-weekly by family health coaches over a 16-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: Baseline, 3 months, 6 months, and 12 months
Glycated hemoglobin as measured by a point-of-care A1c test
Baseline, 3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
The NIH Community Engagement Alliance
Oyate Health Center

Investigators

  • Principal Investigator: Donald Warne, MD, MPH, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00029399
  • OT2HL158287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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